MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number ESP100-21

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adult Respiratory Distress Syndrome (1696); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/29/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 21mm epic aortic valve was implanted in a patient with a history of shortness of breath on exertion and severe aortic stenosis (ava 0.6cm2, vmax 4.1m/s, pgmax 67.0mmhg, pgmean 41.6mmhg).Max velo.=2.88 m/s, max pg=33.2mmh, mean pg=18.4mmhg, eoa=1.47 cm2, dvi=0.28, at=83msec.Ar(-).On (b)(6) 2023, echocardiograms were performed.Lv:dd/ds 40.2/27.7 dilation (-), asynergy(-)ef: 59.4% (teichholz method) 61.9% (simpson method) la: enlargement (-), obvious thrombosis (-) right cardiac system enlargement (-), right ventricular load (-) ivc enlargement (-) pleural effusion (-), pericardial effusion (-).The patient discharged from facility (b)(6) 2023.On (b)(6) 2023, the patients warfarin was discontinued.On (b)(6) 2023, the patient had sudden elevation of nt-probnp was observed in ambulatory follow-up, and dyspnea developed.Heart failure was suspected and diuretic increased.On (b)(6) 2023, an echocardiogram was performed.Max velo.=6.1 m/s, max pg=149 mmhg, mean pg=90 mmhg, eoa=0.4 cm2, dvi=0.12, at=160 msec.Aortic regurgitation trivial.On (b)(6) 2023, the patient respiratory distress improved.Thrombus valve was suspected, and the patient was admitted to the institution.Warfarin was reintroduced on (b)(6) 2023.Echocardiogram result on (b)(6) 2023 showed max velo.=2.8 m/s, max pg=31.4mmhg, mean pg=16.7mmhg, eoa=0.9 cm2, dvi=0.28, at=100 msec.Ar trivial and the patient was discharged home on (b)(6) 2023.When the patient visited outpatient department on (b)(6) 2023, patient¿s respiratory distress had disappeared.Nt-probnp 762.8.On (b)(6) 2023, the patient visited the outpatient department.Nt-probnp 1027.4 epic is not explanted, and the anticoagulation therapy is being carried out.The patient is recovering.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of dyspnea, trivial aortic regurgitation and respiratory distress was reported.It was reported that thrombus was suspected on the valve.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18387515
• MDR Text Key: 331298004
• Report Number: 2135147-2023-05674
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESP100-21
• Device Lot Number: 180730816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 65 KG